Medical diagnostic assays are critical to the diagnosis and treatment of disease, as well as the general maintenance of good health. Particularly useful are the biological and chemical assays performed on whole blood or its components. One early area of development in the field is related to blood typing for the purposes of transfusion. In 1901 Karl Landsteiner discovered that when the blood of one human being was transfused with that of another human being, differences in their blood might well be the cause of shock, jaundice, and the blood disorder hemoglobinuria that had resulted through earlier blood transfusions. Landsteiner classified human blood into A, B, and O groups and demonstrated that transfusions between humans of the same blood group did not result in the destruction of new blood cells and that this catastrophe occurred only when a person was transfused with the blood of a person belonging to a different group. A fourth main blood type, AB was found in 1902 by A. Decastrello and A. Sturli.
From that time, differing blood typing systems have been devised. Historically the naming of blood grouping systems has been disorganized. The common conventions stipulating that dominant traits are given capital letters and recessive traits are designated with lower case letters have not been followed. Also by tradition, red cell antigens were given alphabetical designations or were named after the family of the antibody producer.
The International Society of Blood Transfusion (ISBT) (National Blood Service/Lancaster, PO Box 111, Royal Lancaster Infirmary, Ashton Road, Lancaster LA1 4GT, England) has instituted a numerical system of nomenclature to help standardize red cell blood group terminology. This convention mandates that each system and collection has been given a number and letter designation, and each antigen within the system is numbered sequentially in order of discovery. As of this writing, over 20 blood group systems and seven antigen collections have been defined.
The structure of the antigen determinants for the ABO blood typing system was established in the 1950s by Watkins and Morgan (Nature 180:1038-1040, 1957), and Kabat et al. (Blood Group Substrates: Their Chemistry and Immuno-Chemistry, 1956, Academics Press, New York). Numerous sera and isolated antibodies have been used for ABO blood typing purposes. For example, U.S. Pat. No. 4,764,465 to Foung et al. (1988) entitled “Human Monoclonal Antibody Against Group A Red Blood Cells” is directed to a human monoclonal antibody that directly agglutinates type A human red blood cells. The exemplified antibody is an IgM and is produced by hybrid cells lines S-H22 and HHA1.
More recently, genes encoding the antigenic determinants have also been identified. See for example U.S. Pat. No. 5,326,857 to Yamamoto et al. (1994) entitled “ABO Genotyping” which discloses genes defining the ABO histo-blood groups and methods for the identification of histo-blood group ABO status. The methods described include the use of DNA probes or size separation of DNA fragments unique to a blood group status, DNA constructs, recombinant methods for providing histo-blood glycosyltransferases, methods for tumor suppression, purified histo-blood group glycosyltransferases, and antibodies produced therefrom which bind to protein epitopes.
A variety of apparatuses have been utilized to perform ABO blood typing analysis. For example, U.S. Pat. No. 4,650,662 to Goldfinger et al. (1987) entitled “Portable Blood Typing Apparatus and Method” discloses a portable apparatus to enable rapid determination of an individual's ABO blood group and Rh blood type and a method of using such apparatus. The apparatus has a plurality of microtubes joined together that contain blood taken from an individual. The assembly of microtubes is connected during use to an assembly of reaction chambers containing blood typing reagents. The apparatus enables rapid visualization of the test reactions within the reaction chambers, and may be used in locations removed from a laboratory to determine the ABO blood group and Rh blood type of an individual.
U.S. Pat. No. 5,324,479 to Naldoni et al. (1994) entitled “Analyzer for the Determination of the Phenotype and the ABO Blood Group” discloses an analyzer for the determination of the ABO blood type of a patient. The analyzer comprises a rotatable plate carrying sample-bearing test-tubes and dilution test-tubes arranged along concentric circumferences; a dispensing needle which is movable by mechanical means between a washing position, a position for drawing a sample, a position for diluting the sample and a position for introducing the sample into a reading well; a station for washing said needle; a conveyor unit for conveying carrier members which are provided with twelve reaction wells to a position for receiving diluted or the undiluted samples from the dispensing needle; an automatic feeder that feeds small balls into each of the wells during the forward motion along the conveyor unit; mechanical means for transferring the carrier member to a reading zone; a unit that meters the specific antiserum or red cells into each one of the wells; and an optical reading device that horizontally reads the transmittance of each one of the wells, starting from the moment when antiserum or red cells are introduced; and a processor for functionally controlling the analyzer and for issuing an estimate of the results of the analyses.
U.S. Pat. No. 6,030,581 entitled “Laboratory In A Disc” describes an apparatus that includes an optical disc, having a substantially self-contained assay means for binding an analyte suspected of being in a sample. U.S. Pat. No. 5,892,577 entitled “Apparatus and Method for Carrying Out Analysis of Samples” describes systems and methods for conducting an optical inspection of a biological, chemical or biochemical sample supported by an optical transparent disc.
U.S. Pat. No. 6,143,510, entitled “Measuring Method Using Whole Blood Sample” describes methods for quantitatively measuring analytes in an undiluted whole blood sample by contacting the sample with magnetic particles coated with a binding partner, which binds to an analyte in the sample. There is no description of this assay being carried out on an optical bio-disc. In addition, U.S. Pat. No. 5,993,665, entitled “Quantitative Cell Analysis Methods Employing Magnetic Separation” describes immobilization of microscopic entities into a defined region in a collection chamber such that analysis by automated means is possible. The '665 patent describes quantitative collection of magnetically labeled target entities.
There remains a need in the art of medical diagnostics for more efficient and less expensive diagnostic techniques. As compared to prior methods and systems, we have developed a simple, miniaturized, ultra-sensitive, inexpensive system for imaging and analyzing cells and their components. This system uses optical bio-discs, related detection assemblies, as well as information and signal processing methods and software.